What is Posaconazole?

Posaconazole is an antifungal medication that fights certain infections caused by fungus.
Posaconazole is used to prevent fungal infections in people with weak immune systems resulting from chemotherapy or stem cell transplantation.
Posaconazole may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Posaconazole?

Do not use this medication if you are allergic to posaconazole, or if you are using any of the following drugs:

• halofantrine (Halfan)
• pimozide (Orap)
• quinidine (Cardioquin, Quinidex, Quinaglute); or
• ergot medicine such as methysergide (Sansert), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), methylergonovine (Methergine)

Take posaconazole for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Posaconazole will not treat a viral infection such as the common cold or flu.
Call your doctor if you have ongoing vomiting or diarrhea. Posaconazole may not work as well while during this time.

What should I discuss with my healthcare provider before taking Posaconazole?

Do not use this medication if you are allergic to posaconazole, or if you are using any of the following drugs:

• halofantrine (Halfan)
• pimozide (Orap)
• quinidine (Cardioquin, Quinidex, Quinaglute); or
• sirolimus (Rapamune) or tacrolimus (Prograf)
• ergot medicine such as ergotamine (Ergomar), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine)

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take posaconazole:

• a personal or family history of “Long QT syndrome”
• a history of allergy to antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend)
• liver disease; or
• a heart rhythm disorder

FDA pregnancy category C. It is not known whether posaconazole is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether posaconazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Do not give this medication to a child younger than 13 years old.

Posaconazole Side Effects

What are the possible side effects of Posaconazole?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

• pale skin, easy bruising or bleeding, unusual weakness
• fever, chills, cough, body aches, flu symptoms
• slow, fast, or pounding heartbeats
• feeling light-headed, fainting
• numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes
• confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling
• swelling of your ankles or feet
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure)

Less serious side effects may include:

• mild headache, tired feeling
• joint or muscle pain
• sleep problems (insomnia)
• mild nausea, vomiting, diarrhea, constipation, or stomach pain; or
• skin rash

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Posaconazole Interactions

What other drugs affect Posaconazole?

Many drugs can interact with posaconazole. Below is just a partial list. Tell your doctor if you are using:

• arsenic trioxide (Trisenox)
• cimetidine (Tagamet)
• cyclosporine (Neoral, Sandimmune, Gengraf)
• digoxin (digitalis, Lanoxin)
• droperidol (Inapsine)
• esomeprazole (Nexium)
• midazolam (Versed)
• phenytoin (Dilantin)
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), or rifabutin (Mycobutin)
• an antidepressant
• anti-malaria medications
• a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), nicardipine (Cardene), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), or others
• cancer medicines such as vinblastine (Velban) or vincristine (Oncovin, Vincasar), vindesine (Eldisine), or vinorelbine (Navelbine)
• cholesterol-lowering medicines such as simvastatin (Zocor)
• heart rhythm medication
• HIV medication such as atazanavir (Reyataz), efavirenz (Sustiva), or ritonavir (Norvir, Kaletra)
• medicine to prevent or treat nausea and vomiting, such as metoclopramide (Reglan) or ondansetron (Zofran)
• medicines to treat psychiatric disorders
• migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or
• narcotic medication

This list is not complete and there are many other medicines that can interact with posaconazole. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What should I avoid while taking Posaconazole?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Posaconazole Dosage

How should I take Posaconazole?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Posaconazole works best if you take it within 20 minutes after a full meal or a nutritional supplement (such as Ensure).
Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Call your doctor if you have ongoing vomiting or diarrhea. Posaconazole may not work as well while during this time.
To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.
Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Posaconazole will not treat a viral infection such as the common cold or flu.
Store posaconazole at room temperature away from moisture and heat.

What happens if I overdose on Posaconazole?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a posaconazole overdose are not known.

What happens if I miss a dose of Posaconazole?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
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